2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit
Manufactured by Nanjing Vazyme Medical Technology Co. Ltd., China - www.vazyme.com
Device identification number
291
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Time: 20 minutes
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
200 copies/ml
Positive control
Positive control (RNA pseudovirus)
Negative control
DEPC distilled water
Analytical Sensitivity
100 % (Conformity rate of Positive Control: 100%)
Analytical Specificity
100 % (Conformity rate of Negative Control: 100% tested negative with at least 7 species of microorganisms)
Throughput
single tubes
Type of antigen
SARS-CoV-2 viral proteins (nucleoprotein)
Notes
https://v1.cecdn.yun300.cn/site_1807300040/CD302-02-Manual%20CE%20IVD%200312(1).pdf
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements